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NCT05265676
Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects
Phase 1 trial testing Enoxaparin Sodium (Venus Remedies Limited) in Healthy in 24 participants. Completed in 11 March 2021.
7 March 2021
Quick facts
| Lead sponsor | Venus Remedies Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 26 February 2021 |
| Primary completion | 7 March 2021 |
| Estimated completion | 11 March 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Enoxaparin Sodium (Venus Remedies Limited) — full drug profile →
- Enoxaparin Sodium (Sanofi) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Venus Remedies Limited — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period. The objective of this study is to assess the bioequivalence between the Enoxaparin (Venus Remedies Limited, India) and its innovator product (Clexane®, Sanofi, Germany).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Bioequivalence of a biosimilar enoxaparin (Cloti-Xa™) and its innovator (Clexane<sup>®</sup> ): A single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced study in healthy human subjects.
Saxena S, Chaudhary M, Chaudhary S, Aggarwal A. · · 2022 · cited 1× · PMID 35762448 · DOI 10.1002/prp2.979
Verify or expand the search:
- PubMed search for NCT05265676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Venus Remedies Limited trials
Trials by the same sponsor.
- NCT03477422 — CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05265676 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Venus Remedies Limited
- Last refreshed: 3 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05265676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing